National Bereavement Partnership

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Consent and the Human Fertilisation Embryology
Act 1990
Suzi Leather Chair, HFEA www.hfea.gov.uk
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Outline

• General principles
• Statutory requirements
• Consent to treatment
• Consent to research
• Difficulties with consent
• Monitoring consent
• Review of the Act recommendations

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General principles

• Protect the special status of the human embryo
• Safeguard the interest of those who are storing
  gametes and embryos for future use
• Safeguard the interest of those donating gametes
  and embryos for the treatment of others

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General statutory requirements

• Consent to storage and use of gametes and embryos
  whether for treatment or research must be in
  writing and must not have been withdrawn
  (effective consent)
• Persons giving consent must be given suitable
  opportunity to receive proper counselling and be
  provided with relevant information

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Specific statutory requirementsConsent to
storage of gametes and embryos

• Must specify
• Maximum storage period (if less than statutory
  maximum storage period)
• What should happen to gametes and embryos in
  event of death or mental incapacity

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Specific statutory requirementsConsent to use of
gametes and use and creation of embryos

• Must specify whether this is
• To provide treatment services to patient or
  patient and partner together
• For the treatment of others (donation)
• For research
• Consent to use and creation of embryos
• requires the consent of both gamete providers

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Consent to treatment

• No statutory requirement for written consent to
  treatment that does not involve the creation of
  embryos in vitro
• Code of Practice no licensed treatment (e.g. use
  of gametes to create embryos, placing embryo in a
  woman) is expected to be given to any woman
  without her written consent

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Consent to research

• HFE Act requires written consent but individual
  providing consent may specify conditions subject
  to which gametes or embryos may be used in a
  research project
• Cannot withdraw consent once embryos or gametes
  have been used in project of research

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Research (Code of Practice)

• Centres are expected
• to give donors access to further information
• to inform donors about implications of secondary
  research (e.g. genetic research) and to obtain
  explicit consent for this
• to inform donors about the distinction between,
  and implications of, reversibly and irreversibly
  anonymised research

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Difficulties(i) Donation

• HFE Act no money or other benefits shall be
  given or received unless specified in Directions
• Expenses and benefits in kind may be paid
• SEED review - donors may receive out-of-pocket
  expenses and compensation for loss of earnings
• Donors may receive discounted treatment services

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Difficulties(ii) Withdrawal of consent to storage

• Consent for embryo storage and use needs the
  compatible consent of the egg and sperm provider
  (Natallie Evans case has been heard by ECHR,
  judgment at end of 2005)
• Clinics are expected to make all reasonable
  effort to inform other gamete provider of
  centres obligation to dispose (unless that
  person is a donor)

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(iii) Consent by children and mentally
incapacitated adults

• Consent can only be given by competent adults or
  Gillick competent children, i.e. cannot be given
  by doctor if in the patients best interest or by
  persons with parental responsibility
• HFEA has recommended changes to this in DH
  consultation response in line with McLean review

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Monitoring consent

• Consent procedures are monitored during
  inspections
• Patients receive feedback questionnaires which
  are seen as part of inspection
• In future, questionnaires will contain question
  on consent for research
• Patient complaints direct to HFEA

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Review of the HFE Act

• Retain requirements for written consent
• Implement McLean review and allow storage of
  gametes for children/mentally incapacitated
  person, with appropriate consent, until they
  acquire capacity to consent themselves
• Make consent of one gamete provider sufficient
  for consent to storage to allow for cooling-off
  period in case of dispute